Is early MIDAS reduction at 3 months the best indicator predictor for erenumab treatment continuation? A open-label trial

This database includes the raw data linked with the paper “Is early MIDAS reduction at 3 months the best indicator predictor for erenumab treatment continuation? A open-label trial”, published on The Journal of Headache and Pain.

In this paper, we described migraine disability, quantified as a MIgraine Disability ASsessment (MIDAS).

•             A moderate to severe disability, MIDAS score  11, is required for prescription.

•             Score reduction of at least 50% after the first three months (T3) is mandatory to continue treatment.

•             Primary aim of this study:

•             - to evaluate whether 50% MIDAS reduction at T3 (MIDASRes) is a reliable response predictor of one-year erenumab treatment (classified as a reduction of baseline MMDs 50%).

•             The 50% reduction of monthly migraine days (MMD) at T3 Co-primary outcome

•             Secondary outcomes:

•             - the search of other predictors represents

•             Methods:

•             In this prospective, open-label study, 77 CM patients (mean age 49.8±9.5 years, chronicity history 13.1±10.3years, 93.5% of medication overuse headache) were treated with erenumab 70-140mg subcutaneous injections every 28 days for one year (T13). We assessed demographic and headache features, monthly migraine and headache days (MMD and MHDs respectively), days and doses of symptomatic intake. Patients also completed questionnaires evaluating migraine related disability (MIDAS and HIT-6), psychological comorbidities (HADS-A and HADS-D), quality of life (MSQ and 0 to 100 visual analogue scale) and allodynia (ASC-12). ANOVA for repeated measures was performed for quantifying erenumab efficacy and logistic regression model was used for evaluating one-year predictors of response.

•             Results:

•             Erenumab induced a sustained reduction of MMDs, MHDs and symptomatic intake during treatment. At T13 64.9% of patients presented MMDs baseline reduction 50% (RespondersT13). At T3, 55.8% of patients were MIDASRes. Contextually, 55.4% of patients were MMD Responders, these were also more likely to qualify as RespondersT13 when compared to non-responders (83.3% vs 42.9%; p=0.001). MMD response at T3 also demonstrated to be a predictor of long-term outcome according to a multivariate analysis ((Exp(B)=7.128; p=0.001)). When MIDAS reduction at T3 is considered as decision-making predictor of long-term outcome, 36.0% of patients who may benefit from 1-year erenumab administration are early excluded. By contrast, a lower percentage of Responders T13 (16%) would be discontinued if MIDASRes or MMD responders at T3 were alternatively considered.